Manager, Manufacturing

Manager,저장, Manufacturing – CTMC

Location
:
Houston, TX (Onsite)

Department
:
Manufacturing tlase

Reports to
:
Associate Director, Manufacturing

About CTMC

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, located in the heart of the Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR‑T, TIL, and TCR‑T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.

Since inception in May 2022, our team has filed eight INDs and have received approval,-Identifier, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.

Our growing, state‑of‑the‑art, 60,000 sq. ft. industrial facility in the Texas Medical Center is staffed by an integrated team of industry veterans and academic scientists who are passionate about bringing life‑saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long‑term horizon to achieve our organizational goals.

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure to inspire professional growth and satisfaction. We foster a team‑first culture and a balanced work‑life environment to ensure our staff is energized and engaged in our mission to accelerate cell therapies from bench to bedside for patients who need them. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application.

We look forward to hearing from you and exploring how your skills and expertise can help us achieve ಕುಟುಂಬ.

Responsibilities

• 爵 ævice multiple Cell Therapy or Viral Vector projects simultaneously while successfully coordinating across multiple functional groups to ensure deadlines are met.
• Prepare and deliver reports and data to internal or external parties.
• Subject‑matter expert regarding Cell Therapy equipment:
  Clini Macs Prodigies, G‑Rexes, Incubators, Cell Stacks, Cobes, or Lovos.
• Draft and revise a training program to ensure GMP compliance and operational compliance with cell therapy processes.
• Draft, revise, elaborado high‑level Standard Operating Procedures to govern the use of GMP facilities.
• Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices.
• Perform employee scheduling for multiple simultaneous processes in terms of communication and training standards to work towards a zero‑deviation environment.
• Provide support on IND filings when needed.
• Works with Department Head to establish, drive and report key performance indicators in alignment with Cell Therapy Manufacturing and CTMC goals.
• Conduct thorough investigations in case of deviations on process excursions in close coordination with all relevant functions.
• Other duties as assigned.

Qualifications/Skills

• Bachelor’s degree in a scientific field; or equivalent combination of education and experience.
• 9+ yrs experience in a related manufacturing environment (cell therapy or biotech).
• 3+ yrs previous experience in management or supervisory role.
• Previous experience with TIL therapies in manufacturing preferred.
• Strong knowledge of GMP Practices and FDA requirements required.
• Proficient with manufacturing calculations and conversions.
• Previous experience with standard cleanroom equipment:
  Incubators, BSCs, and centrifuges preferred.
• Previous experience with a QMS system, such as Veeva, Track Wise, or Master Control required.
• Previous experience with preparation and delivery of reports/data to internal or external parties.
• Able to lead and grow an organization of 10+ personnel.
• Previous experience with developing employees, giving employee…